Trial record 1 of 1 for:
"chylomicron retention disease"
Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy
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ClinicalTrials.gov Identifier: NCT01198899 |
Recruitment Status
:
Completed
First Posted
: September 10, 2010
Last Update Posted
: January 12, 2012
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Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
Tracking Information | ||||
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First Submitted Date | August 31, 2010 | |||
First Posted Date | September 10, 2010 | |||
Last Update Posted Date | January 12, 2012 | |||
Study Start Date | July 2009 | |||
Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography [ Time Frame: At baseline T0 ] patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months
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Original Primary Outcome Measures |
Determination of the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography patients with left ventricular hypertrophy will be screened for Fabry mutations, and results will be communicated within four months
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Change History | Complete list of historical versions of study NCT01198899 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy | |||
Official Title | Belgian Screening Project for the Detection of Anderson-Fabry Disease in Hypertrophic Cardiomyopathy | |||
Brief Summary | The purpose of this study is to determine the prevalence of Fabry mutations in patients with left ventricular hypertrophy (moderate to severe), as measured by echocardiography.This study is a screening study | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | patients with left ventricular hypertrophy | |||
Condition | Left Ventricular Hypertrophy | |||
Intervention | Other: blood sampling
Blood sampling will be used. |
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Study Groups/Cohorts | left ventricular hypertrophy
Patients with left ventricular hypertrophy will be used.
Intervention: Other: blood sampling |
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Publications * | Terryn W, Deschoenmakere G, De Keyser J, Meersseman W, Van Biesen W, Wuyts B, Hemelsoet D, Pascale H, De Backer J, De Paepe A, Poppe B, Vanholder R. Prevalence of Fabry disease in a predominantly hypertensive population with left ventricular hypertrophy. Int J Cardiol. 2013 Sep 10;167(6):2555-60. doi: 10.1016/j.ijcard.2012.06.069. Epub 2012 Jul 16. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
540 | |||
Original Estimated Enrollment |
1000 | |||
Actual Study Completion Date | August 2011 | |||
Actual Primary Completion Date | August 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01198899 | |||
Other Study ID Numbers | 2009/035 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University Hospital, Ghent | |||
Study Sponsor | University Hospital, Ghent | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | University Hospital, Ghent | |||
Verification Date | January 2012 |